Evaluation of Safety and Performance of the Omega™ LAA (Left Atrial Appendage) Occluder and Omega™ Delivery System in Patients With Non-Valvular Atrial Fibrillation and High Bleeding Risk

Inclusion Criteria:

1. 18 years of age or older

2. Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF)

3. At increased risk of stroke or systemic embolism defined as a CHA2DS2-VASc score >or = 2

4. To have suitable anatomy for percutaneous Left Atrial Appendage occlusion procedurewith a single Omega™ device

5. Able and willing to comply with the required medication regimen post-device implant

6. Able to understand and willing to provide written informed consent to participate inthe study

Exclusion Criteria:

1. Requires long-term oral anticoagulation therapy for any indication other than atrialfibrillation

2. Contraindicated for or allergic to aspirin, clopidogrel, warfarin or novel oralanticoagulant (NOAC) use

3. Has any contraindications for a percutaneous catheterization procedure (e.g. subjectis too small to accommodate the transoesophageal echocardiogram (TEE/TOE) probe orrequired catheters, or subject has active infection or bleeding disorder)

4. Women of childbearing potential who are, or plan to become, pregnant during the timeof the study (method of assessment per physician discretion)

5. Stroke or transient ischemic attack (TIA) within 6 weeks prior to implant procedure

6. Myocardial infarction (MI) within 90 days prior to implant

7. New York Heart Association Class IV Congestive Heart Failure

8. Left ventricular ejection Fraction (LVEF) < or = 30%

9. Left atrial appendage is obliterated or surgically ligated

10. Actively enrolled or plans to enrol in a concurrent clinical study in which theactive treatment arm may confound the results of this trial

11. Active endocarditis or other infection producing bacteraemia

12. Subject has a known malignancy or other illness where life expectancy is less than 2years

13. Impaired renal function with eGFR <30 ml/min/1.73 m2

Echocardiographic Exclusion Criteria:

1. Intracardiac thrombus - including LAA - visualized by echocardiographic imaging

2. Significant mitral valve stenosis (i.e. mitral valve area <1.5 cm2)

3. Cardiac tumour

4. LAA anatomy cannot accommodate an Omega™ device (as per IFU)

5. Placement of the device would interfere with any intracardiac or intravascularstructure.